FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General & Plastic Surgery ×
18,288 results
2905–2928 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2019
SureForm 45, SureForm 45 Reloads
K183224 · NAY
Intuitive Surgical
General & Plastic Surgery · 59d
Cleared Jan 18, 2019
PICO 7Y Single Use Negative Pressure Wound Therapy System
K182323 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 144d
Cleared Jan 17, 2019
VIVA combo RF System
K183538 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 29d
Cleared Jan 17, 2019
ProgenaMatrix
K182010 · KGN
Cell Constructs I, LLC
General & Plastic Surgery · 174d
Cleared Jan 16, 2019
Laser Hair Therapy
K183329 · OAP
Omm Imports, Inc. D/B/A Zero Gravity
General & Plastic Surgery · 47d
Cleared Jan 16, 2019
Pristine Scope
K183165 · HRX
Pristine Surgical
General & Plastic Surgery · 62d
Cleared Jan 16, 2019
SIRA RFA Electrosurgical Device
K181071 · GEI
Innoblative Designs, Inc.
General & Plastic Surgery · 268d
Cleared Jan 15, 2019
OsteoCool RF Ablation System
K182497 · GEI
Medtronic Sofamor Danek USA, Inc.
General & Plastic Surgery · 125d
Cleared Jan 14, 2019
ZELTIQ CoolSculpting System
K183514 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 27d
Cleared Jan 14, 2019
Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as...
K180570 · FRO
Argentum Medical, LLC
General & Plastic Surgery · 315d
Cleared Jan 11, 2019
ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
K182453 · NUV
I-Tech Industries Srl
General & Plastic Surgery · 126d
Cleared Jan 11, 2019
Senhance Ultrasonic System
K182421 · NAY
Transenterix, Inc.
General & Plastic Surgery · 128d
Cleared Jan 11, 2019
Applied Tissue Technologies PWD™ Platform Wound Dressing
K182409 · OMP
Applied Tissue Technologies, LLC
General & Plastic Surgery · 129d
Cleared Jan 11, 2019
UV Phototherapy
K181805 · FTC
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 189d
Cleared Jan 10, 2019
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX...
K182873 · NEW
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Jan 10, 2019
RENASYS Y-Connector
K181204 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 248d
Cleared Jan 08, 2019
INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
K182868 · MUD
Covidien, LLC
General & Plastic Surgery · 88d
Cleared Jan 07, 2019
Precision Ideal Eyes Arthroscopes
K183470 · HRX
Stryker
General & Plastic Surgery · 24d
Cleared Jan 04, 2019
PicoLO Nd:YAG Picosecond Laser System
K183392 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 28d
Cleared Jan 03, 2019
SculpSure
K182741 · PKT
Cynosure
General & Plastic Surgery · 97d
Cleared Dec 27, 2018
Lotus III Multi-Pulsed Er: Yag Laser System
K182045 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 150d
Cleared Dec 26, 2018
VO200 – NeurOs Cerebral Oximetry System
K182242 · QEM
Mespere Lifesciences, Inc.
General & Plastic Surgery · 128d
Cleared Dec 24, 2018
QuikClot Radial
K181641 · QSY
Z-Medica, LLC
General & Plastic Surgery · 186d
Cleared Dec 21, 2018
Natrelle 133 Plus MICROCELL Tissue Expander
K180826 · LCJ
Allergan
General & Plastic Surgery · 266d